Home NDC 0078-0709 TABRECTA
Product NDC 0078-0709
11-digit product format 000780709
Labeler code 0078
Product ID 0078-0709_0df064bb-358d-4c21-8525-9b8b9a5845a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name capmatinib
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Novartis Pharmaceuticals Corporation
Application NDA213591
Marketing category NDA
Marketing start 2020-05-06
Substance CAPMATINIB HYDROCHLORIDE
Active strength 150 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Kinase Inhibitor [EPC], Mesenchymal Epithelial Transition Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 1 Inhibitors [MoA], Multidrug and Toxin Extrusion Transporter 2 K Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213591-001 TABRECTA CAPMATINIB HYDROCHLORIDE EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 N213591-002 TABRECTA CAPMATINIB HYDROCHLORIDE EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213591-001 12084449 2027-11-19 U-2813 2024-10-02 N213591-001 8461330 2027-11-19 Drug substance, Drug product 2020-05-26 N213591-001 8901123 2029-05-20 U-2813 2020-05-26 N213591-001 8420645 2031-06-05 Drug substance, Drug product 2020-05-26 N213591-001 7767675 2032-11-19 Drug substance, Drug product 2020-05-26 N213591-001 10596178 2035-07-22 Drug product 2020-06-26 N213591-001 12208101 2035-07-22 Drug product 2025-02-03 N213591-002 12084449 2027-11-19 U-2813 2024-10-02 N213591-002 8461330 2027-11-19 Drug substance, Drug product 2020-05-26 N213591-002 8901123 2029-05-20 U-2813 2020-05-26 N213591-002 8420645 2031-06-05 Drug substance, Drug product 2020-05-26 N213591-002 7767675 2032-11-19 Drug substance, Drug product 2020-05-26 N213591-002 10596178 2035-07-22 Drug product 2020-06-26 N213591-002 12208101 2035-07-22 Drug product 2025-02-03
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213591-001 ODE-291 2027-05-06 N213591-002 ODE-291 2027-05-06
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 74 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213591-001 TABRECTA EQ 150MG BASE TABLET / ORAL RLD 2020-05-06 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213591-002 TABRECTA EQ 200MG BASE TABLET / ORAL RLD, RS 2020-05-06 87673890dc5c…
Observed Orange Book patent history# Patent history page 1 of 11 · 402 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N213591-001 12084449 2027-11-19 U-2813 2024-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-001 8461330 2027-11-19 Drug substance, Drug product 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-001 8901123 2029-05-20 U-2813 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-001 8420645 2031-06-05 Drug substance, Drug product 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-001 7767675 2032-11-19 Drug substance, Drug product 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-001 10596178 2035-07-22 Drug product 2020-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-001 12208101 2035-07-22 Drug product 2025-02-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-002 12084449 2027-11-19 U-2813 2024-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-002 8461330 2027-11-19 Drug substance, Drug product 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-002 8901123 2029-05-20 U-2813 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-002 8420645 2031-06-05 Drug substance, Drug product 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-002 7767675 2032-11-19 Drug substance, Drug product 2020-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-002 10596178 2035-07-22 Drug product 2020-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213591-002 12208101 2035-07-22 Drug product 2025-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-001 12084449 2027-11-19 U-2813 2024-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-001 8461330 2027-11-19 Drug substance, Drug product 2020-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-001 8901123 2029-05-20 U-2813 2020-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-001 8420645 2031-06-05 Drug substance, Drug product 2020-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-001 7767675 2032-11-19 Drug substance, Drug product 2020-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-001 10596178 2035-07-22 Drug product 2020-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-001 12208101 2035-07-22 Drug product 2025-02-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-002 12084449 2027-11-19 U-2813 2024-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-002 8461330 2027-11-19 Drug substance, Drug product 2020-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-002 8901123 2029-05-20 U-2813 2020-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-002 8420645 2031-06-05 Drug substance, Drug product 2020-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-002 7767675 2032-11-19 Drug substance, Drug product 2020-05-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-002 10596178 2035-07-22 Drug product 2020-06-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213591-002 12208101 2035-07-22 Drug product 2025-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213591-001 12084449 2027-11-19 U-2813 2024-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-001 8461330 2027-11-19 Drug substance, Drug product 2020-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-001 8901123 2029-05-20 U-2813 2020-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-001 8420645 2031-06-05 Drug substance, Drug product 2020-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-001 7767675 2032-11-19 Drug substance, Drug product 2020-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-001 10596178 2035-07-22 Drug product 2020-06-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-001 12208101 2035-07-22 Drug product 2025-02-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-002 12084449 2027-11-19 U-2813 2024-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-002 8461330 2027-11-19 Drug substance, Drug product 2020-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-002 8901123 2029-05-20 U-2813 2020-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-002 8420645 2031-06-05 Drug substance, Drug product 2020-05-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213591-002 7767675 2032-11-19 Drug substance, Drug product 2020-05-26 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 4 · 144 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TABRECTA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPMATINIB HYDROCHLORIDE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination C2A374O70X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2362234 Internal RxNorm lookup 2362240 Internal RxNorm lookup 2362242 Internal RxNorm lookup 2362244 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0078-0709-56 TABRECTA 56 in 1 BOTTLE TABLET, FILM COATED 56 17 0078-0709-94 TABRECTA 56 in 1 BOTTLE TABLET, FILM COATED 56 17
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0709 TABRECTA (CAPMATINIB) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION] 15 Current NDC, Legacy NDC, 2 package rows 20250403_455892c3-d144-4ba8-9ab4-79cabff9876d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0078-0709-56 00078070956 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-56) 2020-05-06 0000-00-00 No No Current 0078-0709-94 00078070994 56 TABLET, FILM COATED in 1 BOTTLE (0078-0709-94) 2020-05-06 0000-00-00 Yes No Current